Summary
An established biotechnology company needed a technology partner to support them in implementing risk-based quality management (RBQM) and to provide a solution to the lack of visibility into their data. They chose Remarque Systems’ risk-based approach and were equally pleased to find the compelling benefit of dramatically increased output and time savings, with the powerful data visualization and effortless communication made possible by Remarque’s scalable platform.
Customer Introduction
An innovator of treatments for rare diseases, this leading biotechnology company has multiple therapeutic platforms including infusion systems and inhalation technologies, with research and development initiatives in novel biologics and devices; it runs multiple clinical trials concurrently.
The Challenge / How it Affected
The company needed to implement RBQM and maximize compliance with ICH E6 (R2) regulations. Moreover, it had a data issue. There was no single dashboard view into study and site metrics—and the lack of integration was hampering overall trial efficiencies. This included a lack of real-time information access to quickly identify risk and resolve issues before those issues could adversely impact patients, site or study.
To achieve their goals, the company needed data visualization capabilities and automated metrics that generate consistent and accessible data insights—yet, on the surface, many of the different vendor offerings seemed to meet these criteria. How could they choose?
The Solution
On closer examination, it became clear that Remarque Systems has capabilities its competitors don’t, including the ability to be technology agnostic, aggregating data from any system and requiring no additional software or hardware to implement. And beyond the product differentiation, the choice was made even easier based on Remarque’s agility, partnership—and the convenience of monthly installment payments following the initial implementation of the system. A nimble company with a focus on customer service, Remarque spent the time to brainstorm various configurations to find the optimal solution for their client, then was able to offer end-to-end deployment that noticeably abbreviated the implementation timeline.
To achieve their goals, the company needed data visualization capabilities and automated metrics that generate consistent and accessible data insights—yet, on the surface, many of the different vendor offerings seemed to meet these criteria. How could they choose?
The Results
The biotech company was pleased to be aided by the system to follow new ICH E6 R2 guidences, and are on board with RBQM. Yet, they were delightfully surprised by the other advantages afforded by the Remarque System.
- Improved data integration, with live feeds of electronic data from most sources
- Powerful time savings due to the metric design and the fact that numbers refresh and run automatically
- Effortless communication, because all the information is present on the robust dashboard that visualizes site and study data and offers drill-down capabilities
In choosing Remarque, the client adopted both RBQM and a trial-transforming technological advantage.
Case Study
“We knew that implementing Remarque technology would improve our efficiency, but it was impossible to understand how dramatically our efficiency would increase until we actually implemented the technology and experienced the difference. We now do in 30 minutes what used to take a full 8-hour day.”